a study of si-b003 and bl-b01d1+si-b003 in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors

Conditions: Non-small Cell Lung Cancer; Nasopharyngeal Carcinoma

Summary: phase ii: to explore the efficacy, safety and tolerability of bl-b01d1+si-b003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

phase ii: to explore the efficacy of bl-b01d1+si-b003 combination in patients with locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma. to explore the safety and tolerability of bl-b01d1+si-b003 combination in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent form voluntarily and follow the protocol requirements; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old; 4. expected survival time ≥3 months; 5. patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma; 6. consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years; 7. at least one measurable lesion meeting the recist v1.1 definition was required; 8. ecog 0 or 1; 9. the toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by nci-ctcae v5.0; 10. no severe cardiac dysfunction, left ventricular ejection fraction ≥50%; 11. no blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements; 12. coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 uln; 13. urinary protein ≤2+ or ≤1000mg/24h; 14. for premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; all enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment. exclusion criteria: 1. for stage 3 cohort_a, patients with met 14 exon skipping detected by gene sequencing report before signing informed consent; 2. chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 3. had received immunotherapy and developed ≥ grade 3 irae or ≥ grade 2 immune-related myocarditis; 4. use of immunomodulatory drugs within 14 days before the first dose of study drug; 5. history of severe heart disease; 6. qt prolongation, complete left bundle branch block, iii degree atrioventricular block; 7. systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing; 8. active autoimmune and inflammatory diseases; 9. other malignancies diagnosed within 5 years before the first dose; 10. hypertension poorly controlled by two antihypertensive drugs; 11. pulmonary disease was defined as grade ≥3 according to ctcae v5.0; patients with current or history of ild; 12. unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 13. patients with a large amount of serous cavity effusion, or serous cavity effusion with symptoms, or within 4 weeks before signing informed consent; 14. patients with active central nervous system metastases; 15. patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of the test drug; 16. prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis b virus infection or hepatitis c virus infection; 18. active infection requiring systemic therapy; 19. had participated in another clinical trial within 4 weeks before the first dose; 20. the investigator did not consider it appropriate to use other conditions for participation in the trial.